What is NDC 65862-849?

65862-849 is the product NDC for Afirmelle kit, listed with the FDA by Aurobindo Pharma Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Afirmelle (Levonorgestrel and Ethinyl Estradiol).

Aurobindo Pharma Limited, NDC labeler code 65862. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Afirmelle?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Afirmelle NDC 65862-849 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)65862-849Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65862-0849Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
65862-849-88	65862084988	3 POUCH in 1 CARTON (65862-849-88) / 1 BLISTER PACK in 1 POUCH (65862-849-28) / 1 KIT in 1 BLISTER PACKMarketed from Nov 14, 2016
65862-849-92	65862084992	6 POUCH in 1 CARTON (65862-849-92) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACKMarketed from Nov 14, 2016

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Afirmelle
Generic name (nonproprietary): levonorgestrel and ethinyl estradiol
Dosage form: Kit
Labeler: Aurobindo Pharma LimitedNDC labeler code 65862
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 206886
Marketing start: Nov 14, 2016
Listing expires: Dec 31, 2026
Identifiers: Product ID 65862-849_47af327f-2969-4cbf-9aa8-39c8003df043SPL ID 47af327f-2969-4cbf-9aa8-39c8003df043SPL set ID dd6122cd-b7ba-4fe3-bde5-910882475b67RxCUI 242297, 748797, 748868, 1860414UPC 0365862849281

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N465862084988 followed by a unit qualifier and the quantity

Package 65862-0849-88. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Aug 1, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Afirmelle is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table II lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and Norplant ® System, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. % of Women Experiencing an Unintended Pregnancy within the First Year of Use % of Women Continuing Use at One Year 3 Method Typical Use 1 Perfe…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 65862-849

What is NDC 65862-849?: 65862-849 is the product NDC for Afirmelle kit, listed with the FDA by Aurobindo Pharma Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Afirmelle (Levonorgestrel and Ethinyl Estradiol).
Who is the labeler?: Aurobindo Pharma Limited, NDC labeler code 65862. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Afirmelle?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under ANDA 206886

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 206886
Product	Strength	Form · route	Labeler	Product NDC
Aubra EQlevonorgestrel and ethinyl estradiol	—	Kit	Afaxys Pharma, LLC	50102-220
Aubra EQlevonorgestrel and ethinyl estradiol	—	Kit	Bryant Ranch Prepack	63629-5651

Afirmelle (Levonorgestrel and ethinyl estradiol) NDC 65862-849